Aims Specific to Each Phase
Most grant applications require a clearly articulated set of research aims. For NIH proposals, the “aims page” is a single-spaced, one-page narrative that serves as a roadmap to the proposal. Although there is no single way to approach this one critical page, it is typically composed of four major components: an opening paragraph that describes the current state of and gaps in knowledge, and significance of the targeted problem area; a second paragraph that describes the specific purpose of the proposed study and short- and long-term goals, central hypotheses, and the investigative team and environment (e.g., if study builds on previous pilot data, expertise of the team); a third paragraph that outlines the specific study design and the primary aims, and if appropriate, secondary and exploratory aims and associated hypotheses; finally, a fourth paragraph that briefly highlights the innovation of the study, outcomes and expectations, and potential impact on the health of the public. Each paragraph must be written concisely and clearly so that it can be understood by reviewers from diverse backgrounds and disciplines. In essence, this page sets the tone for the reviewers.
The specific aims of a proposed study must reflect testable and measurable statements, each of which are associated with a particular methodology that will be subsequently explained in the proposal narrative. Specific aims will differ depending upon the level of intervention development and specific study purpose. For a grant seeking support for discovery and development of the components or characteristics of an intervention, an example of study aims may be to (a) identify treatment elements leading to a treatment manual that integrates empirically supported treatment and a content review by a panel of experts; (b) conduct an open trial (in which both researcher and participant are aware that a treatment is being provided) with 15 study participants from which to modify the manual through feedback from participants, their caregivers (if relevant), interventionists, and an expert panel; and (c) estimate rates of enrollment and retention and effect sizes through a small trial of 40 study participants.
For a proposal seeking to evaluate an intervention at Phase II, exemplar aims may include (but are not limited to) (a) evaluating acceptance of and engagement in the treatment; (b) testing the reliability and validity of a measure of treatment adherence; and (c) establishing a preliminary effect size for the impact of the intervention through the conduct of a small randomized trial.
For a proposal seeking to evaluate an intervention at the Phase III efficacy phase, aims and associated hypotheses may include (but are not be limited to) (a) testing the effect of the intervention on depression severity (primary outcome) (Hypothesis: Participants in the intervention group will report clinically meaningful and statistically significant reductions in depression severity at 4 months in comparison to participation in an attention control group); (b) testing the longterm effects of the intervention on depression severity and overall well-being at 12 months (Hypothesis: Participants in the intervention group will maintain reductions in depression severity and report improved well-being at 12 months in comparison to participation in an attention control group); and (c) evaluating the cost and cost-effectiveness of the intervention expressed as an incremental cost outcome achieved in the form of depression severity reductions at 4 and 12 months (Hypothesis: The intervention will be cost-effective compared to the control intervention at each test occasion).
Efficacy trials are typically powered to examine one to three primary aims. Secondary or exploratory aims might also be proposed to examine long-term impact, moderator and mediator effects, implementation processes, economic analyses, treatment adherence, and so forth.
The aforementioned exemplars highlight the differences in the scope and nature of aims at different phases of intervention development. However, despite the study phase or the funding agency, the aims of a proposal must be clear, concise, and feasible. It is not prudent to propose a large number of aims in a single application as this may raise questions as to the feasibility of the proposed research.